Coala Life Coala User manual

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USER MANUAL COALA HEART MONITOR

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“Made for iPhone” mean that an electronic accessory has been designed
to connect specifically to iPhone and has been certified by the developer
to meet Apple performance standards. Apple is not responsible for the
operation of this device or its compliance with safety and regulatory
standards. Please note that the use of this accessory with iPhone
may affect wireless performance. iPhone is a trademark of Apple Inc.,
registered in the U.S. and other countries.

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Table of contents
1. Product Description ................................................ 4
2. Indications for Use .................................................. 8
3. Contraindications.................................................... 8
4. Cautions.................................................................. 9
5. Warnings............................................................... 12
6. Storage ................................................................. 15
7. Cleaning and Maintenance.................................... 16
8. Using the Coala ..................................................... 16
9. Coala LED indications............................................ 50
10. ECG Categorization ............................................... 51
11. Troubleshooting .................................................... 56
12. Electrical safety .................................................... 63
13. Transceiver properties........................................... 64
14. Electrical emission................................................ 64
15. Electrical immunity............................................... 65
16.
Warning related to electromagnetic compatibility ... 67
17. Symbols used on system and package label.......... 68
18. Specifications ....................................................... 71
19. Contact information to the Manufacturer.............. 75

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Introduction
Congratulations on your new Coala! Please read this manual
for important safety information and to get the most out of the
Coala Heart Monitor.
1. Product Description
The Coala Heart Monitor is a patented medical device. It
records clinical quality ECG (electrocardiogram) and heart
sounds simultaneously. The device can be used by both
healthcare professionals and health conscious individuals.
Both ECG and heart sounds recordings are available for your
Healthcare professional.
The Coala Heart Monitor consists of the following parts:
• A small hand-held device that is pressed against the chest
for simultaneous recordings of ECG and heart sounds
through electrodes and a stethoscope membrane followed
by a thumb ECG measurement.

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• The Coala app that is installed on a smartphone and is used
to perform measurement together with Coala, collect and
view recordings.The Coala app transmitts recordings to the
Coala Care Portal and receives analyzed results from the
same server. It also features a messaging system where you
can receive notifications from your Healthcare professional.
• A user-supplied compatible smartphone running iOS or
Android, listed on the Coala Life website:
www.coalalife.com/device-compatibility
• Coala Care Portal is the server that provides automatic
detection of the cardiac rhythm deviations, stores all your
recordings and handles your Coala account.
• The
Coala Charge Station that is used to charge the battery
in the Coala.The Coala can be charged from the supplied
wall adapter or any compatible USB outlet. Ensure the
battery is charged regularly, and that it is fully charged
before first use.
• The Coala cover and the travel bag to is provided to protect
the Coala device during transportation and storage.

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The Coala Heart Monitor is intended to be used by a single
individual to:
• Record simultaneous ECG and heart sounds.
• Recieve results from detection of cardiac rhythm deviation.
• Annotate each recording with symptoms or free text.
• Access recordings from the Coala Care Portal and download
pdf file recordings.
• Receive messages from your physician. (If connected
through the Coala Care Portal)
Chest and thumb ECG recordings
The Coala can measure ECG on the chest and on the thumbs.
The measurement on the chest is done by holding the Coala
to the chest and the thumb measurement by gently pressing
both thumbs on the electrode on the bottom of the Coala.
Since the recorded signal depends on the location on the chest,
a finger ECG is also always obtained for reference.

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Simultaneous ECG and heart sound recordings
The mechanical movement of the valves in the heart creates
heart sounds that can be used for assessing the mechanical
condition of the heart. These sounds can be recorded by the
Coala and can be used by a trained medical professional for an
assessment of the heart (when prescribed or used under the
care of a Healthcare professional). The unique Coala feature is
the ability to record simultaneous ECG and heart sounds. This
combined information can be used by a trained cardiologist to
give a detailed view of the electrical and mechanical activity
of your heart.

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2. Indications for Use
The Coala Heart Monitor is intended for self-testing by
patients to record, store, transfer and display surface ECG and
sound to aid the detection of heart and respiratory conditions.
The Coala Heart Monitor is intended for use by healthcare
professionals, individuals with known or suspected heart
conditions and health conscious individuals.
The Coala Heart Monitor is not intended for use for vital
monitoring as in intensive care.
3. Contraindications
There are no known contraindications for Coala Heart Monitor.

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4. Cautions
• Do not use this device in a wet environment. Do not use a
device that has been submerged in water. The Coala device
carries an Ingress Protection (IP) rating of IP22 meaning that
vertically dripping water has no harmful effect when the
enclosure is tilted at an angle up to 15° from its normal (laying
down flat with stethoscope membrane facing down). Note that
the Charge Station, wall adapter and USB cable do not carry
an IP rating and are only to be used in a dry environment.
• Do not use this device in dusty environments such as
machine shops. Use the protective cover and bag to keep
the device clean. Note that the IP22 rating of the Coala
device does not mean that it is dustproof.
• Do not use this device in locations subject to extreme high
or low temperatures or humidity for this reason do not leave
the device in vehicle.
• Do not use a device that shows signs of mechanical damage
or loose parts.
• Do not sterilize this device with an autoclave, gas sterilizer
or using radiation such as gamma or E-beam sterilization.
• Do not take recordings in the presence of strong
electromagnetic fields such as near an arc welder,

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high power radio transmitter etc as these can cause
disturbances to recorded signals. Note that recordings
performed in vehicles (cars, buses, trains, aircraft etc) may
see disturbances due to electromagnetic interference as
from motors and ignition systems.
• Do not expose the device to strong shocks or vibrations.
• Recordings may be interrupted by strong electromagnetic
interference, shocks and vibrations.
• Always protect the membrane from sharp objects such as
keys, pencils etc.
• Do not disassemble, repair or modify the device in any way.
• This device is not intended to be operated by children,
elderly or persons with physical or mental impairment. Let
an able accompanying adult operate the device.
• Do not take recordings if the ECG electrodes are dirty. Clean
them first.
• Do not use for any purpose other than to obtain ECG and
sound recordings.
• The Coala Heart Monitor has not been tested for use on
infants less than 12 months old. Due to chest size and
electrode placement Coala Life does not recommend using
on humans weighing less than 10 kg.